Joyce, my spouse was one of the earliest study subjects for VNS Therapy for Depression (December 13, 1999). I am her long time support person and health care advocate/activist of 5 decades. The intent of the blog is not to promote any therapy, product or treatment but to continue sharing our experiences and knowledge as it relates to VNS. I endorse patient education in collaboration with a caring, knowledgeable and licensed health care professional while also encouraging hope and persistence.

Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

As a brief summary we have a very serious and
potentially life-threatening situation. My spouse Joyce volunteered and
contracted to be a volunteer medical study subject for the newest neuro-modulation
implantable therapy for depression at the time. VNS Therapy (Vagus Nerve
Stimulation) sponsored by Cyberonics Inc. The indication was FDA approved
which then relinquished the sponsor of any further responsibility for patient
medical care. The indication was later denied by CMS (Centers for
Medicare and Medicaid Services) in a national determination document. The therapy has proven remarkably beneficial
for my spouse and other study subjects as well as a number of patients who were
able to acquire the device through Medicare/Medicaid during the brief window of
opportunity between FDA approval and subsequent CMS denial. Despite
having our own health insurance through a United Healthcare Advantage PPO we
all cannot obtain insurance reimbursement for care, services or replacement for
this indication.

I will also point out to you the very same therapy is
FDA and CMS approved for epilepsy.

In the egregious and serious oversight CMS did not consider,
provide
or grandfather care for this small group of patients who are for years doing
well. In turn these patients are saving Medicare/Medicaid tens of thousands of
dollars yearly in hospitalization, medical, medication, doctor etc. costs as a
result of their wellness and now face returning to “The Black Hole” from which they emerged after decades of suffering
and anguish as well as suicide attempts. This small group of study
subjects (my spouse Joyce included) and other patients implanted with the
device are doing well and want to continue with the therapy and will need
replacement when their batteries deplete. They are being denied medical
care and health insurance coverage by CMS, private health insurance carriers
and Cyberonics.The cost for replacement of the device is financially
prohibitive for most patients.

We are real flesh and blood people and not just
numbers as we live our lives independently as best we can and deal with life’s
challenges as they confront us. We struggled for some 36 years with
Joyce’s major depressive illness and 9 suicide attempts. 14 years ago VNS
turned her life around and has given both of us a life. We don’t want to
go back there least of all because someone screwed up through no fault of our
own.

I am asking or really pleading for your help whether
it be you or someone else in authority to understand our plight to make a
compassionate dispensation or whatever appropriate terminology you folks use to
see that these people maintain their wellness and stay off the public dole.

Please feel free to contact me any time, day or night,
as I am working with little sleep trying to get our message heard and acted
upon responsibly and compassionately. I’ll welcome any questions or
concerns you may have.

The purpose of this petition is quite simple and
straight forward, that is to obtain medical care and/or health insurance
coverage for a group of volunteer medical study subjects for an FDA (Food and
Drug Administration) approved therapy and to warn all medical volunteer study
subjects to obtain in writing who is responsible for their medical care if CMS
(Centers for Medicare and Medicaid Services) and/or one’s own insurance company
denies coverage.

FDA approval does not mean or insure medical care or
health insurance coverage.

Background:

On or about 1997 Cyberonics, Inc. received FDA
approval for VNS Therapy for Epilepsy. On or about 1998 Cyberonics additionally
got the go ahead to institute an open pilot study (D-01) for the same VNS
Therapy for Depression. The D-01 was instituted as a result of Epilepsy studies
and patients not only reporting decreases in number and severity of their
seizure activity but also diminishing depression episodes.

Through the assistance and caring of my spouse’s then
attending psychiatrist, Dr. Paul Goodnick, Joyce was enrolled in the D-01 open
study as study subject #46 at MUSC (Medical University of South Carolina) under
the directorship of Dr. Mark George and Dr. Ziad Nahas. She was implanted with
the device on December 13, 1999.

In our desperation at the time and after some 36 years
of Joyce’s continuing severe depressive episodes and suicidal attempts and
failed therapy trials as well as numerous ineffective medications and
refractory treatments, she signed the papers for this newest neuro-modulation
study.

We carefully noted that death was a possible outcome.
We also noted once FDA approved, Cyberonics would no longer be responsible for
her medical care.

What we didn’t know or realize at the time of signing
nor did any of the study volunteers and worse yet the fact that all the other
affiliated parties and medical professionals didn’t take into consideration
when structuring any of these depression studies that with FDA approval it ended
Cyberonics responsibility for medical care but it did not insure
Medicare/Medicaid and/or health insurance coverage for the study subjects. Nor
did anyone know despite FDA approval that CMS would deny coverage for this
medical device (historically the first time such an event took place) left
these volunteer patients in a Catch-22 with an implanted medical device and no
one willing or responsible to pay for medical care despite some of the study
subjects with paid up health insurance but still denied coverage for this
particular therapy.

VNS Therapy, VNS depression studies, Cyberonics, the
former CEO Robert P. (“Skip”) Cummins and the FDA have all been steeped in
controversy and maligned as well. Yet and at the time, when I brought this
loophole to the attention of Mr. Cummins he assured me “not to worry.”

Mr. Cummins honored his words and to his credit, took
action and made a responsible and morally correct pronouncement. He acted and
assured the depression study subjects would have health coverage for the VNS
Therapy if their own health insurance and/or Medicare/Medicaid carriers denied
to cover the therapy by publicly announcing on January 18, 2006:

Similar information was also entered into the
Cyberonics corporate 8-K SEC filings.

Mr. Skip Cummins is no longer with Cyberonics and the
current management has reneged upon their oral and published contract,
commitments and statements. The company has refused to pay for the servicing,
care and replacement of their implantable devices for those volunteer study
subjects (patients) wanting to continue the therapy.

A number of these volunteers, who were devastatingly
ill, are benefiting long-term and living reasonable quality of lives as a
result of VNS Therapy. These patients are being denied health insurance
coverage by their own paid for carriers as well as Medicare/Medicaid despite
the fact the therapy works for them and was FDA approved.

Adding to the illogic of this conundrum is the fact
the very same therapy is covered by Medicare/Medicaid and health insurance
carriers for epilepsy and that some 200 leading psychiatric professionals had
commented during the write-in period to CMS that the therapy should be approved
for coverage based upon their personal patient treatment experiences and that
conventional therapies are ineffective for this unique population of seriously
ill patients.

In the infinite “lack” of wisdom on the part of our
government’s convoluted working agencies to protect us the FDA, CMS as well as
the sponsor and the oath taken by all the medical researchers (to do no harm)
no one thought to ask or provide for health care and replacement coverage for
these medical volunteers. Thereby leaving these study subjects (my spouse
included) with a costly implanted medical device and therapy that no study
subject rightfully or morally should be paying for out-of-pocket especially
since we have health insurance.

CMS in their denial of coverage should have rightfully
grandfathered in the existing study subjects. They did not.

One last and most important point; Joyce and I still
remain advocates for VNS Therapy for Depression as a potentially viable
treatment option to be considered by a reasonably informed patient.

As a result of this therapy my spouse has been
depression free approaching 14 years. We no longer discuss depression. She
takes no antidepressants. Our major concern is to continue maintaining her past
14 year wellness utilizing the same VNS Therapy and to have our paid for health
insurance carrier, Cyberonics and/or any other responsible party honor their
commitments to cover Joyce’s medical expenses and that of the other study
subjects as they do for epilepsy.

At the same time to once again caution and make aware
to other volunteer medical study subjects in any other kind of study to not get
caught up in a very stressful similar and costly situation and negligent
oversight.

I am requesting The United States President, Senate,
Congress, CMS, state and local governmental officials, Health Insurance
Industry, Cyberonics and all medical professionals especially those having
anything to do with VNS Therapy for Depression to do the responsible and
morally correct thing by exerting pressure upon any of the responsible parties
to correct this oversight and injustice by helping these volunteer study
subjects (patients) to obtain medical coverage and to insure future medical
study volunteers are not faced with a similar predicament.

Thank you all for your consideration in reading this
petition and joining in to obtain health care for all medical research study
volunteers.

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About Me

I'm a very, very long-time support person and mental health advocate/activist for my spouse Joyce as well as to others. I'm also a retired business executive and former Board Member, President and facilitator of a local chapter of DBSA as well as a Florida State appointment as a Guardian Advocate. I do not endorse, promote or advertise for any therapy, product or company. I do share our personal experiences, my research and knowledge in the hope it might benefit someone or do I give advice as to what one should or shouldn't do. I extend my best wishes for wellness to one and all and all the good you’d wish for yourselves.